ECHELON ENDOPATH GST45G

GUDID 30705036014908

The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The 45 mm instruments have a staple line thatis approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portionof the shaft to facilitate lateral access of the operative site.The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used reload from being refired.

ETHICON ENDO-SURGERY, LLC

Surgical staple loading unit, non-cutting

• Primary Device ID: 30705036014908
• NIH Device Record Key: 8b572783-bbdc-4a17-a91f-c33ac0b9a8ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECHELON ENDOPATH
• Version Model Number: GST45G
• Catalog Number: GST45G
• Company DUNS: 044606982
• Company Name: ETHICON ENDO-SURGERY, LLC
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705036014904 [Unit of Use]
GS1	20705036014901 [Primary]
GS1	30705036014908 [Package]; Contains: 20705036014901; Package: CASE [420 Units]; In Commercial Distribution
GS1	40705036014905 [Package]; Contains: 10705036014904; Package: CASE [192 Units]; In Commercial Distribution

FDA Product Code

• GDW: STAPLE, IMPLANTABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-02-22

On-Brand Devices [ECHELON ENDOPATH]

• 30705036014922: The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and r
• 30705036014915: The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and r
• 30705036014908: The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and r
• 30705036014892: The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and r
• 30705036014885: The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and r
• 30705036014724: Endopath Echelon Endoscopic Linear Cutter Reloads, Black, 60mm
• 30705036014717: Endopath Echelon Endoscopic Linear Cutter Reloads, Green, 60mm
• 30705036014700: Endopath Echelon Endoscopic Linear Cutter Reloads, Blue, 60mm
• 30705036014694: Endopath Echelon Endoscopic Linear Cutter Reloads, Gold, 60mm
• 30705036014687: Endopath Echelon Endoscopic Linear Cutter Reloads, White, 60mm
• 30705036014595: ENDOPATH ECHELON Vascular Reloads, White, 35mm
• 30705036014366: Endoscopic Linear Cutter Reloads Black 4.4mm, 6 rows
• 30705036013796: Endoscopic Linear Cutter Reloads Gray 2.0mm, 6 rows
• 30705036002448: Echelon Flex 60 Enotpath Stapler Long Articulating Endoscopic Linear Cutter
• 30705036002431: Echelon 60 Endopath Stapler Long Endoscopic Linear Cutter--Staight, No reload
• 30705036001793: Endoscopic Linear Cutter Reloads White 2.5 mm, 6 rows
• 30705036001717: Echelon 45 Endopath Stapler, Long Endoscopic Linear Cutter-Straight (No cartridge), 440 mm
• 30705036001694: Echelon 60 Endopath Stapler, Endoscopic Linear Cutter-Straight (No cartridge)
• 30705036001687: Echelon Flex45 Endopath Stapler, Long Articulating Endoscopic Linear Cutter (No cartridge)
• 30705036001670: Echelon Flex45 Endopath Stapler, Articulating Endoscopic Linear Cutter (No cartridge)
• 30705036001663: ECHELON 45 Endoscopic Linear Cutter Straight 340 mm No cartridge